Merck Vioxx News and Press Releases

THE WASHINGTON POST

January 26, 2005 - A majority of the patients who were persuaded to use prescription arthritis drugs Celebrex and Vioxx would have done just as well on older, cheaper medications and would have avoided the potential heart and stroke risks now linked to those blockbuster drugs, according to a study of how they were marketed.

The two COX-2 inhibitors were promoted with aggressive direct-to-consumer advertising campaigns after their approvals in 1998 and 1999, and the researchers conclude that the marketing played a significant role in leading both doctors and patients to overuse them.

Merck & Co.'s Vioxx was withdrawn last September after a clinical trial linked it to an increased risk of serious heart attacks and strokes, and Pfizer Inc.'s Celebrex remains under a cloud following similar, though less dramatic, reports of the same problem.

The new study finds more than 70 percent of patients prescribed the COX-2 drugs in the first three years they were available were at low or very low risk of ulcers and gastrointestinal problems - the conditions the COX-2 drugs were designed to prevent.

"The fast growth of the COX-2 market took place to a significant extent with patients who could have used" nonprescription alternatives, said study author G. Caleb Alexander of the University of Chicago. "In fact, there are clinical reasons to say they should have been using the alternatives." The COX-2 drugs "were heavily marketed to physicians and the public, and both are known to be susceptible to the impression that newer is better when it comes to medications," he said. "But we know that is not always the case."

A Merck spokeswoman responded that clear policies govern the company's sales and marketing activities, and that "those policies are aimed at ensuring that our product communications are fair and balanced and consistent with FDA labeling." She said the company has training programs in place to make sure that promotions are "consistent with both our standards and our policies."

The new study was published in the journal Archives of Internal Medicine.

Vioxx drug ban hits Merck profits

Vioxx had been linked with an increased risk of heart problems
Profits at US pharmaceutical giant Merck fell 21%, after the firm was forced to withdraw its Vioxx painkiller last year.
Sales of the drug were halted amid safety fears on 30 September, causing a dip in fourth-quarter profits to $1.1bn (£0.59bn), from $1.4bn a year ago.

The firm also added $604m pre-tax to its reserves for Vioxx litigation.

Better-than-expected sales of other key drugs led sales to rise 2.2% to $5.75bn, it announced late on Tuesday.

The firm has not yet established reserves to cover the cost of settling lawsuits from people who claim they have been harmed by using Vioxx.

The drug has been linked with an increased risk of serious heart problems and the company was aware of 575 lawsuits from 1,400 plaintiffs by the end of last year.

Twelve Belgian Vioxx deaths 'probable' claims top doctor

BRUSSELS – 26 January 2005 - At least twelve people are thought to have died in Belgium as a result of taking the controversial painkiller Vioxx. According to a senior advisor to Belgian Health Minister Rudy Demotte, it is "probable" that the twelve patients died as a direct result of taking the drug, La Derniere Heure reported on Wednesday.

"There is a possible relation with Vioxx – possible and even probable, given that on the whole they died from a gastrointestinal haemorrhage, a classic side-effect from taking this type of medicine," said Dr Johan Kips, who coordinates the medicines section of Demotte’s private office. According to La Derniere Heure, Belgian doctors have registered a total of 357 reports of worrying side effects in patients who took the Vioxx.

The majority of cases, which were reported to the Belgian centre responsible for drug safety, concerned gastrointestinal haemorrhages, loss of blood in cells, abdominal and chest pain, ulcers and serious headaches.

Vioxx, developed by the pharmaceutical giant Merck, was generally prescribed for rheumatism and arthritis. It first became available in Belgium in 1999 but it was withdrawn from sale across the world last September after the medical authorities in the US said they were seriously concerned about the drug's safety.

On Tuesday, medical review The Lancet estimated Vioxx could have caused between 88,000 and 140,000 cases of serious cardiovascular diseases in the US alone. Merck is preparing to fight claims from a number of patients who are to sue over the consequences of taking the drug. In 2004, some 30,000 Belgians were treated with Vioxx. The Vioxx scandal has raised doubts about a whole series of other similar drugs.

Kips has advised Belgian still doctors prescribing similar medicines still on the market, such as Celebrex, to do so with caution.

[Copyright Expatica 2005]

Subject: Belgian news

Study finds benefit of older arthritis drugs

Source: Reuters

By Kim Dixon

CHICAGO, May 18 (Reuters) - Older arthritis treatments taken in combination with a heartburn drug may be easier on the stomach than medications such as the recalled painkiller Vioxx that were touted as causing fewer stomach problems, researchers in a drugmaker-sponsored review said on Wednesday.

Arthritis sufferers who had taken Merck & Co.'s <MRK.N> Vioxx and a similar drug withdrawn by Pfizer Inc. <PFE.N> are switching to a mix of older, anti-inflammatory medications taken in combination with a popular heartburn drug to prevent stomach damage.

Taken alone, nonsteroidal anti-inflammatory drugs (NSAIDS) are blamed for up to 16,000 deaths from gastrointestinal bleeding in the United States. Cox-2 inhibitors, which include Vioxx and Pfizer's withdrawn Bextra, were designed to ease pain as effectively as older, nonprescription drugs while being easier on the stomach.

NSAIDS include ibuprofen and naproxen and are sold under brand names such as Advil and Aleve.

The study of the drugs taken in combination, presented at the Digestive Disease Week conference in Chicago and funded by heartburn drug maker TAP Pharmaceuticals, looked at side effects of upset stomachs, but did not look at the more serious problem of gastrointestinal bleeding.

The authors said upset stomach and heartburn are much more common complications of NSAIDs and a significant cost driver.

The broad analysis of data from 32 studies found that the drug combination lessened the risk of upset stomach, versus taking just a Cox-2 inhibitor.

The older arthritis drugs have the added benefit of being cheaper, researchers said.

"In the end it is mostly a cost issue," said Dr. Brennan Spiegel, a study author and physician at the Veteran's Affairs Greater Los Angeles Healthcare System.

"It is also a quality of life issue if ongoing (upset stomach) is not well treated," he said.

But Larry Sasich, a pharmacist at consumer advocacy group Public Citizen, said upset stomach was a weak side effect to examine because it is stomach bleeding that makes the older painkillers risky.

"The issue is protecting people from going to the hospital or dying from gastrointestinal bleeding," he said.

TAP Pharmaceuticals, which funded the study, is a joint venture between Abbott Laboratories Inc. <ABT.N and Japan's Takeda Pharmaceutical Co. Ltd. <4502.T>, which sells the heartburn drug Prevacid.

Because there are few trials directly comparing Cox-2 drugs with the heartburn and arthritis combination, authors used a statistical approach called meta-analysis to combine the findings of 32 studies.

Merck pulled Vioxx from the market last September after it was found to increase the risk of stroke and heart attack. Pfizer later withdrew Bextra at the request of the U.S. Food and Drug Administration after the agency said risk of a life-threatening skin allergy outweighed the drug's benefits.

One major medication in the class, Pfizer's Celebrex, remains on the market.

Since Vioxx was recalled, use of heartburn drugs like AstraZeneca Plc's Prilosec and TAP's Prevacid combined with over-the-counter arthritis drugs has risen. (Additional reporting by Julie Steenhuysen in Chicago)

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